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Opsynvi, macitentan and tadalafil

Named-patient access overview. Opsynvi is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.

About Opsynvi

Opsynvi (macitentan and tadalafil) is manufactured by Janssen and indicated for Pulmonary arterial hypertension (WHO group 1). It is an oral fixed-dose combination (endothelin receptor antagonist + PDE5 inhibitor) approved by the US FDA in 2024 and may be accessible to international patients through Named Patient Program or personal-import pathways.

How Reserve Meds coordinates Opsynvi

  1. Patient or treating physician submits a named-patient request.
  2. Clinical team verifies appropriateness of Opsynvi for the patient and destination country.
  3. Treating physician issues prescription and clinical justification.
  4. Country-specific NPP / personal-import documentation is prepared.
  5. Opsynvi is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
  6. Shipment is coordinated to the patient's physician or hospital pharmacy (cold-chain where required).

Country coverage

Reserve Meds publishes detailed country deep-dives for our most-requested medications. Opsynvi country deep-dives are not yet published; we are expanding coverage as the cohort grows. If you are pursuing Opsynvi for a patient in the UAE, Saudi Arabia, India, Egypt, Pakistan, or another market we serve, submit a request and our clinical team will match the destination to the appropriate regulatory pathway and timeline.

Reserved for you. Opsynvi is in coordination scope for the first cohort. Country-specific pricing and timing are confirmed once a coordinator reviews your case.

Start a request for Opsynvi

Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, timeline, and a formal quote.

Join the Opsynvi waitlist

AI disclosure & medical review. Content on this page is reviewed by Reserve Meds's clinical and regulatory team. Last medically reviewed: .